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510(k) K841865

INNOFLOUR GENTAMICIN by Innotron Diagnostics — Product Code LCQ

K841865 is an FDA 510(k) premarket notification submitted by Innotron Diagnostics for the device "INNOFLOUR GENTAMICIN". The FDA issued a decision of Substantially Equivalent on May 31, 1984. The device falls under product code LCQ (Fluorescent Immunoassay Gentamicin), a Class II device regulated under 21 CFR 862.3450. Innotron Diagnostics has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1984
Date Received
May 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Immunoassay Gentamicin
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
Submission Type

Other clearances by Innotron Diagnostics

  • K850629 — INNOFLUOR THEOPHYLLINE (March 12, 1985)
  • K844721 — INNOFLUOR PRIMIDONE (January 8, 1985)
  • K841866 — INNOFLOUR TOBRAMYCIN (May 31, 1984)
  • K841707 — INNOFLUOR PHENOBARBITAL (May 23, 1984)
  • K841706 — INNOFLUOR PHENYTOIN (May 22, 1984)

Other clearances for product code LCQ

  • K972609 — VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM (August 6, 1997)
  • K955569 — INNOFLUOR GENTAMICIN ASSAY SYSTEM (February 9, 1996)
  • K945523 — COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS (March 9, 1995)
  • K943550 — GENTAMICIN FPIA REAGENT SET AND CALIBRATORS (November 17, 1994)
  • K905721 — OPUS GENTAMICIN (February 21, 1991)
  • K904226 — 'TDXFLX ANALYZER (October 29, 1990)
  • K894523 — FPR GENTAMICIN KIT (September 28, 1989)
  • K852158 — BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA (June 25, 1985)
  • K852013 — GENTAMICIN KIT(FPIA) (June 10, 1985)
  • K843827 — COBAS REAGENTS FOR GENTAMICIN & CALIBRAT (February 1, 1985)

FDA data resources